About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.Stay Connected
My Profile
I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
Posts by Date
June 2023 M T W T F S S 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Twitter List
Legislative Tracking Tools
Category Archives: Industry Image
Release of CMS Medicare Payment Data a Sunshine Dress Rehearsal
There were two major healthcare stories last week. One involved the announcement that Health and Human Services Secretary Kathleen Sebelius would be leaving and the nomination by President Obama of Office of Management and Budget Director Sylvia Mathews Burwell to … Continue reading
Posted in Industry Image, Pharma Industry Image
Comments Off on Release of CMS Medicare Payment Data a Sunshine Dress Rehearsal
Seeking Transparency on Sunshine Act
Yesterday Senators Kohl and Grassley submitted a letter to CMS seeking information on the implementation of the Sunshine Act – the legislation passed and signed into law that would put into place a system for public reporting of the financial … Continue reading
Posted in Industry Image
Comments Off on Seeking Transparency on Sunshine Act
Ups and Downs of Health IT
There was an interesting article this weekend in the New York Times by Robert Pear "Privacy Issue Complicates Push to Link Medical Data" regarding the goal of the incoming Obama Administration to create jobs and great security from medical error … Continue reading
Posted in Industry Image, Legislation
Comments Off on Ups and Downs of Health IT
FTC Report on Generic Drug Deals
No doubt the latest report from the Federal Trade Commission (FTC) Bureau of Competition is going to set the hair of several congresspeople on fire and will perhaps result in a hearing on the matter. The subject of the report … Continue reading
Posted in Generic Drugs, Industry Image
1 Comment
Congressional Hearing on FDA’s Handling of Avandia
I don’t know what the record is for announcing a Congressional investigation after breaking news, but the title may go to Congressman Henry Waxman (D-CA), under whose feet no grass grows. I think he may hold the record. There has … Continue reading
Posted in Drug Safety, FDA Image, Industry Image
1 Comment